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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 78-Gastroenterological & Urological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-3719904-0/1/1 03-Sep-2008 78FDF 3004928439 H B Endoscopy Product United States
 
112-4329621-0/1/2 18-Sep-2008 78FHQ 3007108772 Huaian Wolfram Surgical Instrument China
 
510-5466718-6/4/1 09-Sep-2008 78FIH 1000162947 Jms Co., Ltd. Japan
 
510-5466718-6/2/1 09-Sep-2008 78FIH 1000162947 Jms Co., Ltd. Japan
 
FR1-0012391-3/1/1 22-Sep-2008 78FKP 3000247873 Nipro Corporation Japan
 
510-5466718-6/6/1 09-Sep-2008 78FLC 1000162947 Jms Co., Ltd. Japan
 
T94-0049166-6/7/1 09-Sep-2008 78KNT 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
112-3905754-3/1/1 03-Sep-2008 78KNW 3006175698 Invivo Germany Gmbh Germany
 
AEK-9586082-7/1/1 12-Sep-2008 78LKN 3003675563 Gambro Do Brasil Ltda Brazil
 
112-2357904-9/1/1 24-Sep-2008 78NGQ 3005467097 Hitachi China
 
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